Efficiency Control of Fluticasone/Formoterol K-haler (Medium Strength) vs ICS/LABA (High Strength) in Asthma Patients

Summary

Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.

Conditions

• Persistent Asthma

Interventions

COMBINATION_PRODUCT

fluticasone/formoterol k-haler (medium strength)

2 inhalations every 12 hours

COMBINATION_PRODUCT

Standard of care (ICs/LABA high strength)

Depend of the ICs/LABA combination

Sponsors & Collaborators

• Alpha Bioresearch S.L.

  collaborator OTHER

• Dynamic Solutions

  collaborator INDUSTRY

• Mundipharma Pharmaceuticals S.L.

  lead INDUSTRY

Principal Investigators

• José Luis Velasco Garrido, MD · Hospital Virgen de la Victoria

• Javier Domínguez Ortega, MD · Hospital La Paz

• Patricia García Sidro, MD · Hospital La plana

• Ernesto Enrique Miranda, MD · Hospital General de Castellón

• Ana Gómez-Bastero Fernández, MD · Hospital Universitario Virgen Macarena

• Alicia Padilla Galo, MD · Hospital Costa del Sol

• Fernando Florido López, MD · Hospital San Cecilio

• Joaquín Quiralte Enriquez, MD · Hospital Virgen del Rocío

• Antolín López Viña, MD · Hospital Puerta de Hierro

• Carlos Almonacid Sánchez, MD · Hospital Universitario Ramon y Cajal

• María del Mar Gandolfo Cano, MD · Hospital de Fuenlabrada

• Paula López González, MD · Hospital Infanta Leonor

• Blanca Requejo Mañana, MD · Hospital Central de Asturias

• Ana Pando Sandoval, MD · Hospital Central de Asturias

• Carlos Martínez Rivera, MD · Germans Trias i Pujol Hospital

• Xavier Muñoz Gall, MD · Hospital Vall d'Hebrón

• Gaspar Dalmau Duch, MD · Hospital Joan XXIII

• Luis Alejandro Pérez de Llano, MD · Hospital Lucus Augusti

• Abel Pallarés Sanmartín, MD · Complejo Hospitalario Universitario de Vigo

• Vanesa García Paz, MD · Complejo Hospitalario Universitario de Santiago de Compostela

• Francisco Javier Callejas González, MD · Hospital del Perpetuo Socorro de Albacete

• Patricia Prieto Montaño, MD · Hospital del Perpetuo Socorro de Albacete

• Ana Tabar Purroy, MD · Complejo Hospitalario de Navarra

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-11

Primary Completion

2021-05-31

Completion

2021-05-31